- I would like to know more about innovator generics. Do brand companies with generic lines of products have to submit an ANDA for its own generic? Does FDA see this happening in the United States? Are they treated any differently than traditional generic products?
There is a business strategy where innovator companies are coming up with their own lines of generics. Companies know when a patent or exclusivity is about to expire. About 98 percent of drugs that are off patent have generics competition. What do brand companies do to try to push back? In certain cases, they will, through distributorships, enter into agreements or even have their own distribution companies. They will take that NDA product out of the NDA manufacturing facility, make the tablet a different color, place it in different packaging and then sell it through the distribution arm. For example, if Pfizer is the NDA holder, the product will not be identified as Pfizer, but under the name of the distribution company. This scenario is covered by the new drug process.
If the NDA wants to set up a totally unique company underneath their corporate structure and submit a generic application then that drug would be required to go through the same review process and must meet all the criteria.
Regardless of these scenarios, the active ingredients need to be locked in place, and the inactive ingredient has to have been approved by the FDA Office of New Drugs and limited to the potency that has been approved.